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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K053337
Device Name DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY
BLDG. 500 M.S. 514; POX 6101
NEWARK,  DE  19714 -6101
Applicant Contact YUK-TING LEWIS
Correspondent
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY
BLDG. 500 M.S. 514; POX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact YUK-TING LEWIS
Regulation Number862.3100
Classification Product Code
DKZ  
Date Received12/01/2005
Decision Date 05/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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